Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT03439761
Brief Summary:
Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3 dose escalation design, find Maximum tolerated dose (MTD), Recommended Phase II Dose(RP2D) and evaluate the Pharmacokinetic (PK) profile of PT-112 through Phase I dose escalation stage. Phase I dose confirmation stage: evaluate the safety and tolerability of PT-112 with RP2D, evaluate the anti-tumor effect of PT-112 at RP2D. Phase II stage: evaluate the anti-tumor effect of PT-112 at RP2D in advanced HCC
Detailed Description:
This is a multicenter, open-label, phase I/II clinical trial that includes the dose escalation stage, dose confirmation stage and phase II stage.
In dose escalation stage, a 3+3 trial design is adopted for dose escalation. Three dose groups are designed: 200, 250 and 300 mg/m2, once weekly; 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period. The safety, tolerability, PK and preliminary antitumor effect of PT-112 injection alone are evaluated. After Dose limited toxicity (DLT) evaluation is completed for all the patients in a dose group, the Safety Monitoring Committee (SMC) will evaluate the safety and PK of the dose group based on the resulting data, and decide whether the dose should be escalated, and whether the dosing regimen or PK sampling points should be adjusted.
After dose escalation is completed, the RP2D is selected by SMC for dose confirmation. Dose confirmation study will include approximately 10 patients each of the following six types of tumors:
Group 1: Hepatocellular carcinoma Group 2: Gastric cancer Group 3: Colorectal cancer Group 4: Non-small cell lung cancer Group 5: Head and neck cancer Group 6: Breast cancer If it is difficult to include the patients with a specific type of tumor, or if the tumor is not sensitive to the efficacy of investigational drug, the SMC may discuss and decide to prematurely terminate inclusion of patients in that group.
After sufficient data are obtained in dose confirmation stage, the SMC may discuss and decide to initiate phase II trial. Phase II trial plans to include about 40 subjects to evaluate the anti-tumor effect and safety of the monotherapy in patients with advanced HCC who have previously received only one systemic anticancer therapy.
Study:
NCT03439761
Study Brief:
Protocol Section:
NCT03439761